This is a single arm pilot study for patients with hematologic malignancies with alternative donor sources receiving unrelated or partially matched related/Haploidentical mobilized peripheral stem cells (PSCs) using the CliniMACS system for Alpha Beta T cell depletion plus CD19+ B cell depletion to determine efficacy as determined by engraftment and GVHD, and one year leukemia free survival.
The purpose of this research study is to evaluate a new method of T cell depletion using the Miltenyi CliniMACS™ device for patients undergoing a peripheral stem cell transplant utilizing either a unrelated donor or partially matched/haploidentical related donor. This new method is called α/β (alpha/beta) T cell depletion and CD19+ B cell depletion. This pilot study will evaluate if this new method of T cell and B cell depletion is a more effective way of removing T cells thus reducing the risk of severe acute and chronic GVHD and result in a durable engraftment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Depletion of Alpha Beta T cells in the PBSC graft
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States
Evaluate the engraftment of patients receiving unrelated donor or partially matched related donor peripheral stem cells that have T cell depleted and CD19+ B cell depleted using the CliniMACS device.
Engraftment will be defined using the standard CIBMTR definition of ANC \>500 for the first of 3 consecutive days.
Time frame: DAY 42
Assess the probability of one year leukemia free survival (LFS).
Leukemia relapse is defined as presence of malignant cells in the blood or other body site after initiation of conditioning in a patient previously in remission.
Time frame: 1 year
Estimate the incidence and extent of acute and chronic graft vs. host disease.
Acute GVHD will be graded using the standard Glucksberg grading system.
Time frame: 1 year
Assess the incidence treatment-related mortality (TRM).
TRM is defined as death from non-disease related causes in the 100 days from stem cell infusion.
Time frame: 1 year
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